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Effectiveness of Bazedoxifene for Prevention of Glucocorticoid-induced Bone Loss in RA Patients

NCT02602704 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2020-08-12

No results posted yet for this study

Summary

* The purpose of this study is to study the effectiveness of bazedoxifene in preventing loss of bone mineral density (BMD) and trabecular bone score (TBS), and any fractures in postmenopausal rheumatoid arthritis (RA) patients receiving long-term GCs.
* This is a randomized, controlled, open-label extension study for 48 or 56 weeks. At study entry, all patients will receive elemental calcium (1200 mg daily) and vitamin D (800 IU daily) and will be randomized by blocks of two to receive either bazedoxifene (20 mg/day) or none.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

Bazedoxifene

Bazedoxifene 20mg/day (Viviant) for 48 weeks

DRUG

Calcium/Vit D

Elemental calcium 1200mg daily and vitamin D 800 IU daily (Caltrate D 400 \* 2/day) for 48 weeks

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Hanyang University

    lead OTHER

Principal Investigators

  • Yoon-Kyoung Sung, MD, PhD, MPH · Hanyang University Hospital for Rheumatic Diseases

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-29
Primary Completion
2017-10-11
Completion
2018-12-01

Countries

  • South Korea

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02602704 on ClinicalTrials.gov